Z-2296-2010

V. Mueller Peanut Sponges, Catalog number 23275-470, Sterile, For Single Use Only, Size: 3/8, X-Ray...

Name: Z-2296-2010 V. Mueller Peanut Sponges, Catalog number 23275-470, Sterile, For Single Use Only, Size: 3/8, X-Ray...
Creator: He, Inc
Published: 2010-03-01
License: https://open.fda.gov/license/

He, Inc / initiated 2010-03-01 / Terminated / root cause: packaging

FDA source

He, Inc began a recall of V. Mueller Peanut Sponges, Catalog number 23275-470, Sterile, For Single Use Only, Size: 3/8, X-Ray Detectable In Holders, Distributed by Cardinal Health... on 2010-03-01. The reason FDA records is "Sterile product packaging contains weak seals, which may result in compromised product sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2296-2010
Status: Terminated
Initiated: 2010-03-01
Posted: 2010-08-27
Terminated: 2011-11-02
Recalling firm: He, Inc
Product: V. Mueller Peanut Sponges, Catalog number 23275-470, Sterile, For Single Use Only, Size: 3/8, X-Ray Detectable In Holders, Distributed by Cardinal Health, McGaw Park, IL 60085 USA. There are various uses including as gauze/sponge internal, x-ray detectable and as dissectors.
Product code: GDI Dissector, Surgical, General & Plastic Surgery
Reason for recall: Sterile product packaging contains weak seals, which may result in compromised product sterility.
Root cause tag: packaging
FDA root cause: Packaging
Action: Harod Enterprises, Inc. (HE) issued a "Notice of Recall" letter to Cardinal Health/V. Mueller dated March 1, 2010 identifying the issue and affected product. Cardinal Health/V. Mueller will issue a subrecall letter to all their customers (end users) instructing them to discontinue use of the affected lots and return for replacement. and will track all responses and removal of the product from their private label customers. HE will repackage and/or replace all returned product. Consignees can contact Harod Enterprises, Inc. at 1-706-228-5165.
Quantity in commerce: 551 cases of 100 packages per case
Distribution: Nationwide: including state of IL.
Product codes and lots: Product Code: 23275-470, Lot number 3405

Product code GDI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)